Ivermectin In Treatment of COVID 19 Patients

June 8, 2020 updated by: Dr. Ehab kamal, Ministry of Health and Population, Egypt

The Use of Ivermectin In the Treatment of COVID 19 Patients

as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

the study will compare the effect of ivermectin in comaprison and addition to the standard mode of care for the COVID 19 patients

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • isolation and referal hospitals for COVID 19 patients
        • Contact:
          • ehab ah kamal, MD
          • Phone Number: 01006162663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral RNA swap

Exclusion Criteria:

  • Contraindications for the drug: hypersensitivity.
  • Any medications with possible drug interactions.
  • Severe cases.
  • Any malignant condition.
  • Pregnant females.
  • Breast feeding females.
  • Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A ivermectin alone
ivermectin will be administarted alone to COVID 19 patients
Drug: Ivermectin
use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
Other Names:
  • hydroxychloroquine
Experimental: B standard care alone
standard care will be administarted alone
Drug: Ivermectin
use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
Other Names:
  • hydroxychloroquine
Active Comparator: C ivermectin added to standard of care
ivermectin will be administarted in adition to standard care
Drug: Ivermectin
use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
Other Names:
  • hydroxychloroquine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to evaluate the role of Ivermectin as a line of treatment for COVID 19
Time Frame: 2 months
the role of ivermectin in the cure of COVID 19 patients
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To asses the rate of viral clearance in comparison to other treatment protocols.
Time Frame: 2 months
to compare the results of ivermectin with the standard care
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health and Population, Egypt

Investigators

  • Study Director: houssam ho masoud, MD, COVID sceintific comittee ministry of health and population

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-2020/3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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